The Cell Therapy Working Group (CTWG)’s primary goals are open discussion and sharing of best practices for the regulation of cell and tissue-based therapies, as well as support of harmonization initiatives.
1. General considerations
As an emerging product category, cell and tissue-based therapies became a topic for the Regulators Forum in 2011. Since then the group has held 2-3 teleconferences per year and two in-person meetings. The group has established a set of operating principles utilizing a stepwise approach to identify topics for regulatory convergence. The approach includes (1) surveys to identify topics of interest; (2) scoping exercises to determine the regulatory landscape for specific topics (3) Identification of topic leads and co-leads; (4) developing the scope of the topic; (5) collection of information on the topic; (6) drafting of a communication of results. The Group has two ongoing projects that will continue to evolve as new members join and changes are made to existing regulatory approaches: a compilation of regulatory frameworks for participating countries, and a list of scientific and regulatory terminology used in each region.
The primary goals of the Working Group are information sharing and regulatory convergence.
Objectives are as follows: (1) open discussion and sharing of best practices for the regulation of cell and tissue-based therapies; (2) support harmonization initiatives such as APEC; (3) refer topics to appropriate organizations such as ICH, PIC/S, PANDRH, WHO.
3. Scope (of activities)
The products to be discussed in this group include cell therapy products without gene modifications, tissue-engineered products, and xenotransplantation products.
The scope of activities in this group is as follows:
- To discuss regulatory challenges and potential topics/areas for harmonization or convergence regarding cell therapy products
- Identify possible topics for harmonization or regulatory convergence by conducting scoping exercises to identify commonalities and differences in regulatory approaches
- To explore information-sharing processes with other international (ICH) and regional bodies (APEC, PANDRA, etc.) and to collaborate in terms of training of international regulators
- At each meeting or teleconference, a roll call of regulatory updates to include new regulations, new guidance or guidelines, and recently approved products takes place. An annual compilation of updates will be prepared to keep participants up-to-date on current activities for each region.
The cell therapy working group is comprised of international regulatory authorities and persons representing harmonization initiatives (APEC, WHO, and PAHO), interested in the convergence of regulatory approaches for cell and tissue-based therapies.
Deliverables may be communicated by postings on the IPRP website, and the publication of White Papers, journal manuscripts or ICH Considerations papers.